Guidance Notes for University Ethics Reviewers
Introduction
An Ethics Reviewer’s responsibility is to ethically review research ethics applications within the University’s
ethics review procedure.
If you feel that you would benefit from advice on the role of an ethics reviewer and cannot find what you
need on the University’s research ethics website at http://www.bradford.ac.uk/gateway/research/researchsupport-for-academics/ethics/ , then please contact Lynda Nuttall, the Secretary to the University’s
Committee for Ethics in Research in the Research Support Unit, ext. 3170.
Annex 1 provides advice on what issues to look out for when reviewing a research ethics application.
PLEASE NOTE:
1. before completion of the Research Ethics Application applicants have already completed a checklist
at http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/ResearchEthicsApprovalProcess/ in order to identify the need for full ethical
review.
2. The name of the Reviewer of any application will be kept confidential and all comments will be
completely anonymised before circulation to applicant.
The University’s Ethics Review Procedure
On average it is expected that it will take approximately 10 working days to ethically review an application
(i.e. from receipt of a fully completed application through to the applicant being informed of the ethical
decision).
Ethics Reviewers should feel able to consult the Chair of the Committee for Ethics in Research or the
Chair of the Research Ethics Panel for advice on ethical issues concerning research applications.
See the website at http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/CommitteeforEthicsinResearch/SchoolEthicsRepresentatives/ for a list of the current
Ethics representatives in each School.
Also see http://www.bradford.ac.uk/gateway/research/research-support-for-academics/ethics/ for the list of
Research Ethics Panel representatives.
The University Ethics Administrator in the Research Support Unit will seek to ensure that there is an
equitable spread of workload between Ethics Reviewers, in terms of the number of requests for reviews.
Having identified the Ethics Reviewers in liaison with the Chair of the Research Ethics Panel, the Ethics
Administrator will then provide the Reviewers with an electronic copy of the information received from the
applicant (e.g. the research ethics application form and other documents where relevant, i.e. information
sheet, consent form). The University Ethics Administrator will have checked that all the required
information has been supplied and has been fully completed before forwarding it on to the Ethics
Reviewers.
Ethics Reviewers will be expected to confirm that they have no conflict of interest with the application that
the University Ethics Administrator has asked them to ethically review (this is confirmed by default by the
reviewer completing and returning the “Ethics Reviewer’s Comments Form”). This form is available for
download at Stage 5 on page http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/ResearchEthicsApprovalProcess/
Version 1 dated July 2008
If both Ethics Reviewers find the research uncontentious the Chair can take action to approve the project
without it going to a meeting of the Research Ethics Panel.
Otherwise the application form and reviewers’ forms will go to the next meeting of the appropriate Research
Ethics Panel.
For information only, the University Ethics Administrator will inform all the Ethics Reviewers involved what
the final ethics review decision is.
Contentious Research Ethics Applications
Where the Ethics Reviewers do not agree that the project is uncontentious it will be ethically reviewed by a
Research Ethics Panel. The Ethics Administrator in the Research Support Unit will arrange this.
In very exceptional cases, i.e. where the Research Ethics Panel cannot itself reach a consensus about an
application, then the application will be reviewed by the University’s Committee for Ethics in Research.
Appeals
If, with regard to any application, the ethics review outcome is that the application should NOT be approved,
then the applicant reserves the right to appeal against the decision by contacting, in the first instance, the
Ethics Administrator in the Research Support Unit. The Ethics Administrator will then arrange for the
Research Ethics Panel to ethically review the application. If this Panel decides NOT to approve the
application then the applicant reserves the right to appeal against this decision again and the application
will be considered by the Committee for Ethics in Research.
IT MUST BE RECOGNISED THAT THE DECISION BY THE COMMITTEE FOR ETHICS IN RESEARCH
WILL BE FINAL.
Guidance Notes for University Research Ethics Reviewers
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ANNEX 1
ISSUES TO CONSIDER WHEN REVIEWING AN ETHICS APPLICATION
1.
Ethics Reviewers should pay particular attention to how projects intend to:
1.
2.
3.
4.
5.
6.
7.
8.
protect the dignity, rights, safety and well-being of participants;
obtain consent from participants;
inform participants about the purpose, methods and use of the research;
safeguard the anonymity of participants;
protect the confidentiality of information relating to participants
ensure compliance with data protection;
protect researchers, particularly those conducting research off campus;
protect the reputation of the University.
Ethics guidance on the above issues is provided in the University’s Code of Practice for Ethics in
Research which can be found at: http://www.bradford.ac.uk/gateway/research/research-supportfor-academics/ethics/EthicsPolicyandStrategy/
It is especially important to pay attention to these issues when:
9. research involves ‘particularly vulnerable human participants’
10. research focuses on ‘highly sensitive subject topics’ (e.g. race, ethnicity, political opinion,
religious beliefs/other beliefs of a similar nature, physical or mental health condition, sexual
life, abuse (child, adult), nudity, obesity, people affected by conflict situations (e.g. ethics,
religious, tribal, conflicts/wars));
11. research involves covert research methods;
12. there is no evidence that either explicit or implicit consent is being sought.
2.
General Concerns
1. Is there likely to be a worthwhile outcome? (For example, is the methodology or sample
size adequate to achieve the study’s intended aim?)
The purpose of the ethical review is not to conduct a scientific review but it must be of
sufficient merit to warrant the time and effort contributed by research participants. It is
recognised that student research will normally be of relatively lower scientific merit but the
project should be of a suitable standard to achieve the educational aims and objectives.
2. An Applicant has not answered questions in sufficient detail (e.g. stating that the
identities of participants will be anonymised without explaining the anonymisation procedure
to be established).
3. Technical Terms, Jargon and Abbreviations:
The avoidance of this is particularly important in the case of participant information sheets,
which need to be clear and simple and easily understood by a lay person (i.e. need to
provide sufficient but clear information to enable participants to make an informed choice
when deciding whether or not to participate in the research).
4. Potential for ‘Pain’:
Nearly all projects involving participants have the potential to cause pain, discomfort, stress
(physical and/or psychological) for the participants, however minor. Projects should at least
recognise this potential and explain what plan of action they would take, if any, should
participants experience pain, discomfort or stress. As part of the review the potential risks
should be balanced against the potential benefits.
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5. Projects involving the taking of blood samples from participants:
Projects should explain what plan of action, if any, they would take if they noticed any
incidental abnormalities in the blood samples.
6. Illegal Issue/Practice(s):
If a participant informed a researcher of an illegal issue/practice(s) not related to the
research project (e.g. occurring where s/he worked), what plan of action would the
researcher take, if any?
7. Potential Benefit(s):
Not all projects will benefit the participants directly but might serve ‘the public good’.
Applicants could state how their projects might benefit the public good.
8. Inducements
There should not be evidence of bias or coercion or any inappropriate inducements to
persuade people to participate in research.
3.
Issues which should be addressed in any review:
1. How appropriate is the study design in relation to the study’s objectives?
2. Has there been an assessment of the risks/benefits for the participants?
3. How have the predictable risks and inconveniences been justified in relation to the
anticipated benefits for participants (concerned communities, wider public)?
4. How safe is the intervention to be used in the proposed research?
5. Will there be impact on the local community?
6. What steps have been taken to consult with the concerned communities during the course of
the study design process?
7. Are the participants’ rights to physical and mental integrity and privacy and protection
safeguarded?
8. What measures have been taken to ensure the confidentiality and security of personal
information concerning research participants?
9. To what extent will information about participants be anonymous?
10. How will initial contact and recruitment be conducted?
11. Where research subjects are unable to write, has provision been made for consent to be
obtained orally with at least one witness?
12. How will information be conveyed to potential participants or their representatives?
13. Is the information given appropriate, complete and understandable?
14. How will consent by obtained?
Oral or implied consent is acceptable in some circumstances but this must be justified (for
example, the act of completing and returning a questionnaire implies consent).
How will consent for the acquisition of personal data/samples be obtained?
15. What are the inclusion criteria for participants, and are they justified?
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16. What is the justification for including in the research individuals who cannot consent? What
arrangements have been made for obtaining the consent of such individuals?
17. What are the exclusion criteria for participants and are they justified?
18. What statistical methodology will be employed (including sample size calculation)? What is
the potential for reaching a sound conclusion with the smallest number of participants?
19. Who will have access to the personal data of the participants with justification?
20. Will the participants incur any financial costs as a result of their participation in the research?
21. Will the participants receive any rewards/compensation for their participation in the study?
22. What are the criteria for prematurely withdrawing participants?
23. What steps will be taken if participants withdraw?
24. Will the study product be made available to the participants following the research?
25. How long will the data/samples be kept?
26. How will they be stored?
4.
Issues to Consider in respect of Research involving Children:
1. Appropriate consent procedures must be in place from either the child or parents, depending
on the child’s competence.
2. The applicant should confirm the research results cannot be obtained from any other group
of participants.
3. The protocol should ensure that the consent obtained represents the child’s presumed will
and can be revoked at any time without detriment to the child.
4. The protocol should ensure the child receives information on risks and benefits according to
their capacity to understand from staff experienced with children.
5. The protocol should ensure the explicit wish of the child to refuse to participate or withdraw
at any time is considered and acted upon by the Principal Investigator.
6. The protocol and participant information sheet should make clear that no incentives or
inducements are given, apart from reasonable travel and out of pocket expenses where
warranted.
7. The research design/protocol/participant information sheet should address the need to
minimise pain, discomfort and fear and other foreseeable risks. There should be provision to
monitor and report on any of these issues.
5.
Issues to consider in respect of Research involving Incapacitated Adults not able to give
Informed Consent
1. The protocol should ensure the person has received information according to their capacity
to understand, regarding risks and benefits.
2. The research design/protocol/participant information sheet should address the need to
minimise pain, discomfort and fear and other foreseeable risks.
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